Chapter I: General provisions

Dispensing pharmacists who dispense a blood-derived medicinal product must immediately transcribe the information mentioned in article R. 5132-10, the patient’s date of birth and the information appearing on the detachable label of the outer packaging onto a special register, which must be listed and initialled by the mayor or the police commissioner, or record it immediately using any system approved by the Minister for Health. If a transcription is made…

In healthcare establishments and other establishments with an in-house pharmacy, blood-derived medicinal products are dispensed by the in-house pharmacy on the basis of a medical prescription. The in-house pharmacy attaches to the medicinal product a numbered slip, known as a dispensing and administration slip, on which it records the following information: 1° The name of the prescriber and the department to which he belongs ; 2° The surname, first names…

In the establishments referred to in Article R. 5121-187, the person administering the blood-derived medicinal product to the patient completes the dispensing and administration slip with the following information: 1° The patient’s surname, forenames and date of birth ; 2° The date of administration; 3° The dose administered. It mentions the dose administered and the date of administration on the prescription kept in the medical record and affixes a label…

When the in-house pharmacy dispenses a blood-derived medicinal product directly to a patient, the information referred to in article R. 5121-187 is transcribed onto a special register marked and initialled by the mayor or police commissioner, or recorded by any system approved by the Minister for Health.

Exceptionally, after consultation with the managing pharmacist, by decision of the director of the health establishment or the administrator of the Groupement de Coopération Sanitaire, departments may have a supply of blood-derived medicinal products intended for urgent care. This supply is managed in accordance with the provisions of the order provided for in article R. 5132-42. When a medicinal product is taken from the supply provided for in the previous…

In health establishments and health cooperation groups authorised under article L. 6133-7 to carry out the tasks of these establishments which do not have an in-house pharmacy which hold blood-derived medicinal products under the conditions mentioned in article L. 5126-6, the supply of blood-derived medicinal products gives rise to the recording by the correspondent mentioned in article R. 5121-181, in a special register marked and initialled by the mayor or…

In blood transfusion establishments and in any organisation other than pharmacies, health establishments and health cooperation groups authorised to dispense blood-derived medicinal products, these medicinal products are dispensed on the basis of a named medical prescription. When medicines are dispensed, the information referred to in article R. 5121-187 is recorded in a special register which is listed and initialled by the mayor or police commissioner, or by any other system…

When a healthcare professional administers a blood-derived medicinal product outside healthcare establishments or the establishments and organisations mentioned in article R. 5121-192, he/she affixes a detachable label from the immediate packaging of the unit administered to the original prescription kept by the patient. When the medicinal product is administered by a doctor, the latter affixes the other detachable label of the immediate packaging of the unit administered to the medical…

The formalities of transcribing, recording and drawing up the forms provided for in this paragraph take the place of the transcriptions and recordings mentioned in article R. 5132-10.

The registers or records provided for in articles R. 5121-185 to R. 5121-193 are kept for a period of forty years. Where necessary for the purposes of pharmacovigilance, the regional pharmacovigilance centres have access to these documents.